WOCKHARDT LTD FDA Approval ANDA 079112

ANDA 079112

WOCKHARDT LTD

FDA Drug Application

Application #079112

Application Sponsors

ANDA 079112WOCKHARDT LTD

Marketing Status

Over-the-counter001
Over-the-counter002
Over-the-counter003
Over-the-counter004
Over-the-counter005
Over-the-counter006

Application Products

001TABLET;ORAL30MG0CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE
002TABLET;ORAL30MG0CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE
003TABLET;ORAL60MG0FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE
004TABLET;ORAL60MG0FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE
005TABLET;ORAL180MG0FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE
006TABLET;ORAL180MG0FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2012-02-08

Submissions Property Types

ORIG1Null7

CDER Filings

WOCKHARDT LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79112
            [companyName] => WOCKHARDT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"FEXOFENADINE HYDROCHLORIDE ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"FEXOFENADINE HYDROCHLORIDE ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"180MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"FEXOFENADINE HYDROCHLORIDE HIVES","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"FEXOFENADINE HYDROCHLORIDE HIVES","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"180MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"FEXOFENADINE HYDROCHLORIDE ALLERGY","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"FEXOFENADINE HYDROCHLORIDE ALLERGY","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"180MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"FEXOFENADINE HYDROCHLORIDE HIVES","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"FEXOFENADINE HYDROCHLORIDE HIVES","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"180MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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